BETAMETHASONE VALERATE aerosol foam

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

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Prenos Lastnosti izdelka (SPC)
13-01-2018

Aktivna sestavina:

BETAMETHASONE VALERATE (UNII: 9IFA5XM7R2) (BETAMETHASONE - UNII:9842X06Q6M)

Dostopno od:

RICONPHARMA LLC

INN (mednarodno ime):

BETAMETHASONE VALERATE

Sestava:

BETAMETHASONE VALERATE 1.2 mg in 1 g

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

                                BETAMETHASONE VALERATE- BETAMETHASONE VALERATE AEROSOL, FOAM
RICONPHARMA LLC
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BETAMETHASONE VALERATE FOAM, 0.12%
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Betamethasone Valerate Foam, 0.12% contains betamethasone valerate,
USP, a synthetic corticosteroid
for topical dermatologic use. The corticosteroids constitute a class
of primarily synthetic steroids used
topically as anti-inflammatory agents.
Betamethasone valerate is
9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,
20-dione 17-
valerate, with the empirical formula C
H FO , a molecular weight of 476.58. The following is the
chemical structure:
Betamethasone valerate is a white to practically white, odorless
crystalline powder, and is practically
insoluble in water, freely soluble in acetone and in chloroform,
soluble in alcohol, and slightly soluble
in benzene and in ether.
Betamethasone valerate foam, 0.12% contains 1.2 mg betamethasone
valerate, USP, per gram in a
thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol,
citric acid, ethanol (60.4%),
polysorbate 60, potassium citrate, propylene glycol, purified water,
and stearyl alcohol pressurized
with a hydrocarbon (propane/butane) propellant.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, betamethasone valerate foam has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
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PHARMACOKINETICS :
Topical corticosteroids can be absorbed from intact healthy skin. The
extent of percutaneous absorption
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